Procedure description

Project leader InSilicoTrials

How can the regulatory aspects for medical devices and drugs be supported from such in silico trials, and what is the best exploitation model? This could be assessed either within the cloud-based platform developed in the project or directly through companies that have partners interested in exploiting these tools directly. InSilicoTrials  will design a clear exploitation strategy to commercialise the in-silico products particularly towards EU companies to enhance their competitiveness and growth.

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Opportunities for exploitation

An augmented platform for in-silico trials

The integration of new models on the platform

The platform developed by InSilicoTrials will allow users to set up and run simulations from all over the world in a very simple way and on-demand. The platform collects a variety of tools to be used by companies and institutions in the healthcare sector. New models will populate the library of available tools, making it more and more appealing to a greater number of potential customers. Such platform can really help worldwide users to cut their expenses while benefiting from computational tools with high scientific value.

A platform for testing new product designs

The platform of InSilicoTrials will allow to verify and validate new designs of pacing leads/devices and their interaction with the heart in terms of efficacy and safety. The model will have been thoroughly verified and validated therefore trustworthy. Given its standardisation, it will be feasible to use it on new designs.

A Cloud-based platform as a vector to promote disruptive technology.

This platform will offer an interface for health researchers and professionals to run simulations, part of which will be performed by ExactCure. This will be an opportunity to discover an innovative approach to personalised pharmaco-kinetics meta-modelling, and potentially use it for other diseases.

Tools for personalised medicine

Personalised medicine with MicroPort products

Beyond the virtual population, physician could have access to a “digital twin” of the patient to tailor treatment using Microport  products. This could be an add-on to the outcome of SimCardioTest at a later stage.

Bring results into the hands of healthcare professionals and patients

ExactCure also develops a « Digital Twin » mobile app, as well as an online simulation tool, that will bring SimCardioTest results into the hands of people to whom it will be useful in their everyday life to better use drugs.

In-silicotrials and regulation

The compliance with new regulatory requirements

During the project, the platform will be refined and improved with new software protocols and components to comply with EU and US standards and guidelines related to the use of modeling and simulation in healthcare. This will constitute a competitive advantage for InSilicoTrials in its market proposition.

In-silico trials recognised to support regulatory approval

The output of the simulation shall provide reports that will abide by the latest regulatory guidelines/standards and will have demonstrated sufficient credibility for the regulatory authorities to accept the in-silico trials and computer simulations outcome as a full part of the design verification test of the future product to be commercialized.

New product & knowledge

SOFA cardiac simulator @Inria

New biomarkers to improve clinical trial designs/methodologies

Using the virtual population, more cases will be evaluated than possible with a clinical trial and results of the in-silico trials and new biomarkers shall help design safer, more cost-efficient clinical trials to validate new products or demonstrate their superiority to current existing products. Patient groups could be identified, statistical power and sample size could be estimated based on the results of the in-silico trials.

Scaling down from body- to cell-level modelling

ExactCure‘s technology simulates drug concentrations in blood or plasma. During the project, the partners will work on how to derive those concentrations at the surface of a cell. This key learning will then be applicable to other diseases, and is expected to open significant new business opportunities to ExactCure.

Adapted Device

Fluid dynamic indices from the simulations like the recirculation zones, stagnant flows, shear-stress related indices will be used to identify device related thrombus risk indices.

The know-how behind the integration activities

InSilicoTrials will interact with partners to understand the complexity of the models and their integrability. This will allow InSilicoTrials to embed the experience and expertise gained from this project into the procedures adopted for the creation of disruptive cloud solutions.